Ensuring that pharmaceuticals are of the same quality during every individual production run is an essential regulatory requirement.
To meet this, CombiGene and CGT Catapult have collaborated to develop a tailor-made package of analytical assays to ensure that the production of the AAV1 based gene therapy CG01 meets these regulatory requirements.
CGT Catapult experts developed seven unique assays in order to characterise the various viral vector components and their performance. The methods to conduct these tests will now be transferred to the CDMO selected by CombiGene to manufacture their AAV drug material for clinical use. These assays are mandated by regulatory requirements so completion of their development to suitable standards of reproducibility, accuracy and precision is a significant milestone.
“It is very gratifying that we have now concluded the work on the analytical methods together with CGT Catapult. It has been challenging work both technically and scientifically. This is another important step in securing the production of CG01”, says Karin Agerman, Chief Research & Development Officer at CombiGene.
Matthew Durdy, CEO at CGT Catapult commented: ”CombiGene is an innovative gene therapy company working in an important area of unmet medical need. The availability of reliable and meaningful assays for manufacturing control is an issue for the industry and an area in which we set out to increase innovation and capability. This successful collaboration with Combigene has done that, and will further the development of this therapy for the benefit of patients with epilepsy.”
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